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Managing Obesity by Combining Behavioral Weight Loss and Commercial Approaches

This study has been completed.
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Angela M Pinto, Baruch College City University of New York
ClinicalTrials.gov Identifier:
NCT00827593
First received: January 22, 2009
Last updated: April 12, 2012
Last verified: April 2012
History of Changes
  Purpose

The purpose of this study is to examine the effectiveness of 3 behavioral weight loss programs- Weight Watchers, university-based behavioral weight loss treatment, and a combined approach which includes university-based treatment followed by Weight Watchers.


Condition Intervention
Obesity
 Behavioral: Standard behavioral weight loss treatment
Behavioral: Weight Watchers
Behavioral: Combined Treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Managing Obesity by Combining Behavioral Weight Loss and Commercial Approaches

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Baruch College City University of New York:

Primary Outcome Measures:
  • weight loss [ Time Frame: 3, 6, 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • cost-effectiveness [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 144
Study Start Date: November 2008
Study Completion Date: October 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Standard behavioral weight loss
University-based behavioral weight loss treatment
 Behavioral: Standard behavioral weight loss treatment
Participants will receive 12 months of university-based behavioral weight loss treatment
Active Comparator: Weight Watchers
Weight Watchers program
 Behavioral: Weight Watchers
Participants will receive 12 months of Weight Watchers
Active Comparator: Combined Treatment
University-based behavioral weight loss treatment followed by Weight Watchers
 Behavioral: Combined Treatment
Participants will receive university-based behavioral weight loss treatment followed by Weight Watchers

  Eligibility

Ages Eligible for Study:   30 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age between 30-65 years
  • BMI between 27-50 kg/m2
  • Written approval/consent from primary health care provider

Exclusion Criteria:

  • Unable to walk 2 blocks without stopping.
  • Currently participating in a weight loss program or taking weight loss medication.
  • Participated in a weight loss program in the last year
  • Took weight loss medication in the last 6 months.
  • Participated in Weight Watchers in last 2 years.
  • Lost >=5% of body weight during 6 months prior to screening.
  • Pregnant, lactating, less than 6 months postpartum, or plan to become pregnant during study time frame.
  • Report conditions that in the judgment of the principal investigator would render them potentially unlikely to follow protocol for the 12 month study.
  • Report a medical condition that would affect the safety and/or efficacy of a weight management program involving changes in diet and physical activity.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00827593

Locations
United States, New York
Baruch College
New York, New York, United States, 10010
Sponsors and Collaborators
Baruch College City University of New York
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Angela M Pinto, PhD Baruch College
  More Information

No publications provided

Responsible Party: Angela M Pinto, Assistant Professor of Psychology, Baruch College City University of New York
ClinicalTrials.gov Identifier: NCT00827593     History of Changes
Other Study ID Numbers: 070601
Study First Received: January 22, 2009
Last Updated: April 12, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Obesity
Weight Loss
Overnutrition
Nutrition Disorders
 Overweight
Body Weight
Signs and Symptoms
Body Weight Changes

ClinicalTrials.gov processed this record on May 19, 2013